Status:
COMPLETED
Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity (RVTOX)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Central Neurogical Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of the study is to investigate the effect of exposure to a virtual reality session during botulinum toxin injections on injection-induced stress. The secondary objectives are to st...
Detailed Description
Botulinum toxin injections is very frequently used in the treatment of spasticity after central neurological damage (stroke, multiple sclerosis, spinal cord injury, head trauma). The injections may be...
Eligibility Criteria
Inclusion
- Adult patient, male or female, suffering from spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) and eligible for treatment by botulinum toxin injection
- Able to give an informed consent to participate in research
- Affiliation to Social Security.
Exclusion
- Contraindication to virtual reality (epilepsy, schizophrenia, strabismus, amblyopia, anisometropia, local contraindication to wearing a helmet (lesion of the face or the skull)
- Major cognitive disorders
- Any medical condition deemed by the investigator to be incompatible with the research.
- Indication of sedation by MEOPA during botulinum toxin injection sessions.
- Patients who have already experienced virtual reality
- Drug treatment or medical condition that may affect heart rate variability
- Pregnant or breastfeeding women
- Patients under safeguard of justice
- Refusal of participation.
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05364203
Start Date
May 10 2022
End Date
December 2 2024
Last Update
September 24 2025
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, France